Clinical Research Coordinator

The Clinical Research Coordinator will perform independently or with general direction at the fully operational journey level of the series to execute, manage, and coordinate research protocols, as directed by the Clinical Research Supervisor and/or Principal Investigator (PI); may coordinate the data collection and operations of several concurrent clinical research studies under the guidelines of research protocols, UCSF and regulating agency policies.

Incumbent’s duties may include, but will not be limited to supporting the management and coordinating the tasks of single or multiple clinical research studies, depending on their size and complexity; act as intermediary between services and departments while overseeing data and specimen management; manage and report on study results; create, clean, update, and manage databases and comprehensive datasets and reports; coordinate staff work schedules, assist with training of Assistant CRCs, and assist Clinical Research Supervisor and/or PI with oversight of other research staff; manage Investigator’s protocols in the Committee on Human Research online system, as well as renewals and modifications of protocol applications and the implementation of new studies; participate in the review and writing of protocols to ensure institutional review board approval within University compliance; help assure compliance with all relevant regulatory agencies; oversee study data integrity; implement and maintain periodic quality control procedures; interface with departments to obtain UCSF approval prior to study initiation; maintain all regulatory documents; report study progress to investigators; participate in any internal and external audits or reviews of study protocols; and perform other duties as assigned.

Involves analytical studies on a variety of policies, projects, programs and issues in support of a function, research initiative, program and / or organizational unit, or in research of new or changing systems and programs. Assists in policy and program planning, development, administration, management and implementation; interprets, monitors and analyzes information regarding policies and procedures and provides consultative services to department administrators and other stakeholders.

Under the direction and supervision of the Principal Investigator (PI) – Dr. Orlando Harris, the Clinical Research Coordinator will mainly conduct data collection, engage in participant recruitment activities, serves as a center coordinator for the California Center for HIV Syndemic Policy Research (CalCenSyn), strong community engagement with local and state-level community-based organizations, and coordinate lab meetings with graduate research assistants, and coordinate meetings across several state and National Institute of Health sponsored projects.

This position requires a strict adherence to protocols and guidelines, with an emphasis on organizational skills and meticulous attention to detail. In addition, the successful candidate must possess a warm and nonjudgmental manner, and consistently demonstrate interpersonal tact, discretion, and sensitivity when interacting with study participants. These different job aspects are unique processes requiring specific experience and skill sets, and the Clinical Research Coordinator must blend and balance all areas to ensure the successful completion of research data collection and outcomes.

Department Overview: The UCSF School of Nursing was founded in 1939 as the first autonomous School of Nursing in any state university, the USCF School of Nursing was the first university west of the Mississippi to offer a doctoral degree in nursing. The UCSF School of Nursing was ranked number 3 in the US News America’s Best Graduate Schools 2016. Since 2003, the school has been ranked first or second in NIH funding, with almost $14 million in 2021.

It is designated as a World Health Organization Collaborating Center in Nursing. The UCSF School of Nursing is home to 533 students distributed across five units: the Departments of Physiological Nursing, Family Health Care Nursing, Community Health Systems, Social and Behavioral Sciences, and the Institute for Health and Aging. The PhD program includes 120 doctorally prepared faculty members, of whom 48 actively support the doctoral program.

A Center for Symptom Management promotes cross-departmental and multidisciplinary research focusing on interventions to prevent and alleviate symptoms. A number of other centers of research excellence investigate significant problems in acute and chronic care, and policy. The Department of Community Health Systems (CHS) is based in the school of nursing.

CHS promotes and sustains health in the community and workplace, with particular emphasis on culturally diverse and high-risk populations. The department is committed to improving health and health care for those served by community-based health care systems through educating culturally competent nurses, conducting research, and providing services in the community which address the health issues of those underserved by the traditional institution-based health care system.

CHS carriers out research on a broad range of HIV-related topics both nationally and internationally, strongly encourages multidisciplinary collaborations across campus, and hosts frequent research seminars and quarterly half-day workshops on emerging, novel research methodology. Faculty research in CHS contributes to our understanding of the effects of disease or conditions on vulnerable populations including: homeless and disadvantaged people and communities, persons with psychiatric disorders and issues of trauma and abuse, high-risk infants and children, individuals with chronic diseases like asthma, cardiovascular disease, diabetes and HIV, and ethnic and immigrant minorities.

Responsibilities % of time ( Nothing less than 5%) Essential Function (Yes/No ) Key Responsibilities (To be completed by Supervisor) 30 YES Study Coordination and Data Collection Identify subjects, develop recruitment and retention strategies, and screen and enroll study subjects. Schedule subjects for study visits; meet with them to administer questionnaires, collect medical history and perform study procedures. Maintain rapport and relationships with subjects to ensure effective communication and retention; respond to their diverse needs, schedule follow-up appointments, and become their intermediary; discuss study outcomes with providers to ensure continuity of care.

Obtain informed consent; review information with subjects; assess and advocate for patient safety throughout each protocol procedure. Oversee subject reimbursement; work to resolve discrepancies and issues. Work with staff to ensure procedures are completed, specimens properly stored, and required data collected at visits; and ensure correct shipping and labeling measures.

Coordinate, communicate and network with other studies and technicians to ensure scheduling efficiency; communicate with any affiliated groups. Conduct reviews of medical charts and electronic records to extract medical information and other data for use in studies. Implement needs assessments and recommendations for enhancements on patient coordination, data collection, data management, protocol adherence and study collaboration.

The primary responsibilities will be: Study start-up activities: test assessment surveys, draft study procedures and forms; Participant recruitment: implementing online and outreach activities and recruitment strategies, preparing and distributing outreach materials, developing and maintaining referral options for ineligible participants, maintaining the study’s recruitment database, providing recruitment reports to the project team; Data collection: conducting phone screenings, scheduling and conducting online consent protocols and survey interviews, arranging phlebotomy visits, maintaining participant databases; Participant retention: reminder calls, texts and emails, monthly check-ins, and Other duties as assigned by the PI and PD, e.g., performing data entry, cleaning and coding data, attending and participating in team meetings, administration of qualitative control interviews. 20 YES Data management and reporting of results Collect data during subject visits; enter data from visits, procedures, lab tests, and other subject-related participation into databases in a timely manner.

Manage database structure for each protocol; update databases to improve data analysis and management; create new databases as needed. Create and maintain comprehensive data sets as requested by the CRC Supervisor and/or PI. Maintain data collection forms for effective data collection, entry, and analysis.

Perform queries and analysis in databases. Work with Supervisor to maintain complete and accurate data in the study database; analyze the data as they become available. 5 Staff training Help train staff and others on new research protocols, changes in procedures, study protocols, data collection/entry, database procedures, medical chart review and storage, and other procedures. Attend and actively participate in regular team meetings Oversee data integrity; initiate assessments of the adequacy of existing policies and procedures on subject recruitment, data collection, and data management.

Update and maintain a procedure manual documenting all study-related procedures; help develop a plan to ensure consistency in data collection and data entry. Implement and maintain periodic quality control procedures Suggest modifications to the administrative infrastructure to accommodate increasing complexity of studies. Modify data collection instruments Help schedule staff time and coordinate staff schedules.

Maintain subject tracking systems. 5 YES Quality control procedures 20 YES Study Implementation 15 YES Protocol Submissions and Adherence Enter all existing and new study protocols into the Committee on Human Research (CHR) online system; seek assistance on maintaining all protocols in the system by communicating with CHR Analysts. Design and enhance case report forms and data collection forms as needed; provide manuscript feedback; continue to develop and maintain systems for assuring protocol adherence and data quality.

Participate in the review and writing of protocols and related procedures to ensure institutional review board approval within University compliance. Renew, modify, and submit CHR applications and protocols; ensure that protocol applications are submitted in a timely manner; serve as a liaison between CHR and study Investigators. Provide quality assurance checks to note if protocols or UCSF CHR applications need to be modified; evaluate protocols on an ongoing basis and implement improvements as needed. 5 YES Regulatory responsibilities Assure studies are carried out according to Code of Federal Regulations, Good Clinical Practice, and UCSF regulations.

Initiate and follow-up on CHR submissions and modifications; track approval status. Interface with departments to obtain UCSF approval prior to study initiation. Maintain regulatory documents; monitor timelines for data submission; document adverse events and submit to appropriate departments.

Use sound judgment to maintain patient confidentiality when communicating with agencies, healthcare providers, other studies, and outside departments. Participate in and cooperate with any internal and external audits or reviews of study protocols; prepare necessary documentation. 10 0% (To update total %, enter the amount of time in whole numbers (without the % symbol - e.g., 15, 20) then highlight the total sum (e.g., 1%) at the bottom of the column and press F9.

The total sum should add up to 100%.)

Full time · Day shift Required Qualifications HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training. Attention to detail; strong interpersonal skills; excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments and outside institutions; and the ability to multi-task in a fast-paced environment while working with a diverse subject population.

Ability to work well independently, complete projects in a timely manner, and prioritize multiple projects to ensure the completion of essential tasks by deadlines.

Fluency in the usage of Committee of Human Research (CHR) online iMEDris system for submission, renewal, and modification of protocols through this system. Understanding of patient population to create rapport and a relationship, while also giving insight to what is realistic and appropriate for patient participation. Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals Experience with electronic medical records.

Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPPA regulations, following the UCSF mission statement and purpose for research, and a clear understanding of policies and procedures on patient safety and confidentiality (electronic and hard copy medical records, patient charts, communication, etc.); knowledge of medical terminology, research policies and guidelines, guidelines for packing/shipping infectious substances, database building/analysis, and data management within some of the following: Access, Stata, SASS/ SPSS, and Teleform programming platforms.

Experience applying the following regulations and guidelines: Good Clinical Practice Guidelines Health Information and Accountability Act (HIPAA) The Protection of Human Research Subjects CHR regulations for recruitment and consent of research subjects Effective Cash Handling Procedures Environmental Health and Safety Training Fire Safety Training